Saturday, July 13, 2024

DEA Reschedules Marijuana Drug Epidiolex

Although marijuana remains illegal at the federal level in the United States, there will soon be cannabis-based medicine sold in major pharmacies like CVS, Walgreens and Rite Aid. A drug known as Epidiolex, which is derived entirely from cannabidiol or CBD, was recently listed a Schedule V by the U.S. Drug Enforcement Administration.

This rank on the agency’s Controlled Substances Act allows the drug special privileges when it comes to distribution on the pharmaceutical market. Not only is it considered entirely legal to possess and use with a prescription, but it is also considered “medicinal” above all other cannabis products manufactured and sold in legal states across the nation.

It was earlier this summer when the U.S Food and Drug Administration (FDA) made history by giving the green light for the first even cannabis-based drug for distribution on the U.S market.

Although synthetic cannabis medicines, like Marinol, have been around for decades, the approval of Epidiolex, which was developed by British drug company GW Pharmaceuticals, marks the first time a substance made entirely from cannabis has been listed anything other than a Schedule I – a rank that suggests “no known medicinal value.”

Some cannabis advocates believe the Epidiolex deal is a sign that federal marijuana prohibition is on its last leg.

“This is a major shift for FDA/DEA,” attorney David Holland, legal counsel to High Times Magazine, wrote in a Twitter post. “National cannabis legalization should be 18 months or less from here.”

But it might still be too soon to make that call.

Although Epidiolex is marked for Schedule V – a classification that means it has proven medical function with a low potential for abuse – no other form of CBD has been given this consideration.

“As of right now, any other CBD product other than Epidiolex remains a Schedule I Controlled Substance, so it’s still illegal under federal law,” said a spokesperson for the DEA.

This means that Epidiolex will be perfectly acceptable to use as a means for treating children with certain forms of epilepsy, but the law stops there. CBD products purchased from state-licensed medical marijuana dispensaries are still considered violations of federal law. The FDA-approved drug will cost patients an estimated $32,500 per year. But unlike other cannabis medicines, it will be covered by most major health insurance plans.

Still, the cannabis advocacy community is skeptical.

“The DEA’s rescheduling of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis. However, it remains to be seen to what degree physicians will be comfortable prescribing this new agent, and whether most patients can feasibly afford it,” said Paul Armentano, deputy director at NORML.

“We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant,” he added. “These are welcome alternatives. But these products should not be regulated in such a manner that patients no longer have ready access to herbal cannabis — a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 31 states.”

Although most major pharmacy chains like Walgreens, CVS, and Walmart have not yet confirmed their intentions to carry the drug, Rite Aid says it will.

“Rite Aid pharmacists fill prescriptions in accordance with all state regulations and laws as well as those set forth by the DEA and FDA,” Rite Aid spokeswoman Ashley Flower told CNN. “Given that Epidiolex has received approval from the FDA, upon being rescheduled, Rite Aid expects to fill prescriptions for Epidiolex later this year based on availability.”


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